Johnson & Johnson’s Seltorexant Achieves Significant Improvement in Depressive Symptoms and Sleep Disturbance in Phase 3 Trial

1. Positive Phase 3 Results: Johnson & Johnson's investigational drug, seltorexant, has shown statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes in patients with major depressive disorder (MDD) with insomnia symptoms.
2. First-in-Class Therapy: Seltorexant is an investigational first-in-class selective antagonist of the human orexin-2 receptor being studied for the adjunctive treatment of MDD with insomnia symptoms.
3. Unmet Need: Approximately 60% of MDD patients on standard-of-care oral antidepressants experience residual insomnia symptoms, highlighting the high level of unmet need.
4. Phase 3 Study Details: The randomized, double-blind, multicenter, placebo-controlled study achieved all primary and secondary endpoints.
5. Additional Data: Positive topline results for SPRAVATO (esketamine) CIII nasal spray as a monotherapy were also presented, demonstrating rapid and sustained efficacy in treatment-resistant depression (TRD).
6. Presentation: The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.